Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (NCT03313778)

🧪 Interventions in This Study

• mRNA-4157 (BIOLOGICAL)
• Pembrolizumab (BIOLOGICAL)
• SoC Treatment (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Parts A, A2, and D: Participants must be clinically disease-free at study entry (that is, participants in the adjuvant setting).
2. Part B: Participants must have one of the histologically- or cytologically-confirmed unresectable (locally advanced or metastatic) protocol-specified solid malignancies, have measurable disease at study entry defined by RECIST 1.1., and be considered suitable for treatment with pembrolizumab; in this study pembrolizumab will be considered an investigational study drug.
3. Part C: Participants must have one of the histologically- or cytologically confirmed unresectable (locally advanced or metastatic) protocol-specified solid malignancies, must not have received prior anti-programmed cell death protein 1 (PD-1)/programmed death -ligand 1 (PD-L1) therapy, and must have measurable disease at study entry defined by RECIST 1.1.
4. Part A2: Participants with histologically confirmed PDAC who have undergone complete macroscopic resection(that is, R0 - no cancer cells within 1 mm of all resection margins or R1 - cancer cells present within 1 mm of one or more resection margins) who had no evidence of metastatic disease with adequate recovery from surgery to receive adjuvant therapy.
5. Parts E1 and E2: Participants with untreated histologically/cytologically confirmed Stage II-IIIB NSCLC (per AJCC version 8) that is considered resectable of non-squamous (adenocarcinoma only) or squamous cell carcinoma histology, absence of major associated pathologies that increase the surgery risk to an unacceptable level, must have a tumor tissue sample available for NGS and PD-L1 IHC testing as defined in the Laboratory Manual.
6. Part E3: Participants with untreated, locally advanced surgically resectable, histologically/cytologically confirmed, gastric/GEJ adenocarcinoma, as defined by a primary lesion that is T3 or greater or with the presence of any positive clinical nodes (N+) and without evidence of metastatic disease, measurable disease according to RECIST version 1.1, absence of major associated pathologies that increase the surgery risk to an unacceptable level, must have a tumor tissue sample available for NGS and PD-L1 IHC testing as defined in the Laboratory Manual.
7. Part D: Participants with completely resected Stage II, III or IV cutaneous melanoma.
8. Parts A, A2, and D: Participants must have a formalin-fixed paraffin embedded (FFPE) tumor sample available (for example, from their prior surgery) that is suitable for the next generation sequencing (NGS) required for this study.
9. Parts B and C: Participants must have at least 1 lesion amenable to the mandatory fresh tumor biopsy at study entry.
10. Participants must have resolution of toxic effect(s) (as specified in the protocol) from prior therapy to Grade 1 or less.
11. Participant is willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug (male and female participants of childbearing potential), or for a specified time after the last dose of SoC chemotherapy per SoC product labeling, whichever is later.
12. Participants with Performance Scale (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (20 Sites)

• Angeles Clinic and Research Institute — Los Angeles, California
• The George Washington Cancer Center — Washington D.C., District of Columbia
• Orlando Health Cancer Institute — Orlando, Florida
• Florida Cancer Specialists — Sarasota, Florida
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
• Massachusetts General Hospital — Boston, Massachusetts
• NYU Langone Medical Center — New York, New York
• The Cleveland Clinic Foundation — Cleveland, Ohio
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
• UT Southwest Medical Center — Dallas, Texas
• St Vincents Hospital Sydney — Darlinghurst, New South Wales
• Westmead Hospital-Cnr Hawkesbury and Darcy Road — Westmead, New South Wales
• One Clinical Research Perth — Nedlands, Western Australia
• National Cancer Center East — Kashiwa-Shi, Chiba
• National Cancer Center Hospital — Chuo-Ku, Tokyo
• The Cancer Institute Hospital of Japanese Foundation For Cancer Research — Tokyo,
• Kindai University Hospital — Osakasayama-Shi, Ôsaka
• Ninewells Hospital - PPDS — Dundee, Scotland
• Royal Mardsen Sutton — Sutton, Surrey
• Imperial College Healthcare NHS Trust Hammersmith Hospital — London,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Solid Tumors

• Phase II Biomarker Study of BND-22 in Combination With Cemiplimab in Solid Tumors — Houston, Texas
• Study of AUBE00 in Patients With Solid Tumors — Grand Rapids, Michigan
• JAB-2485 Activity in Adult Patients With Advanced Solid Tumors — Detroit, Michigan
• Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors — Basking Ridge, New Jersey
• Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours — Edmonton, Alberta
• DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors — Los Angeles, California

Explore by condition: All Solid Tumors clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.